The following data is part of a premarket notification filed by Third Wave Technologies, Inc. with the FDA for Invader Ugt1a1 Molecular Assay.
| Device ID | K051824 |
| 510k Number | K051824 |
| Device Name: | INVADER UGT1A1 MOLECULAR ASSAY |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. Madison, WI 53719 -1256 |
| Contact | Sam Rua |
| Correspondent | Sam Rua THIRD WAVE TECHNOLOGIES, INC. 502 SOUTH ROSA RD. Madison, WI 53719 -1256 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-08-18 |
| Summary: | summary |